FDA applicant

Laser Engineering Heart, Inc.

Nashville1 decision1998–19980 recalls

FDA records 1 decision for Laser Engineering Heart, Inc. (Nashville) in 1998: 1 original PMA approval. All are in product code MNO (System, Laser, Transmyocardial Revascularization). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Laser Engineering Heart, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Laser Engineering Heart, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Laser Engineering Heart, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Laser”

FDA records each applicant name separately; these may or may not be the same firm.

Laser Industries, Ltd. 20 Laser Engineering, Inc. 18 L.A.S.E.R., Inc. 14 Laser Photonics, Inc. 14 Laser Media 13 Laser Peripherals, LLC 12 Laser-Optik-Systeme GmbH & Co. KG 7 Laser Spectrum, Inc. 5 Laser Max Medical Technologies Corp. 4 Laser Surgical Systems 3 Laser Associated Sciences, Inc. 2 Laser Dental Innovations 2

Laser Engineering Heart, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Laser”